Over-the-counter drug · ANDA
Clotrimazole NDC 49348-793
Clotrimazole 10 mg/g · Cream · Vaginal · Strategic Sourcing Services LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49348-793-76 | 49348079376 | 1 TUBE in 1 CARTON (49348-793-76) / 45 g in 1 TUBEMarketed from Jul 19, 1993 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Clotrimazole
- Generic name (nonproprietary)
- clotrimazole
- Active ingredients
- Clotrimazole — 10 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074165
- Marketing start
- Marketing end
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 49348-793_c2c4de79-b6f4-4bbe-9c40-35acb45419a7SPL ID c2c4de79-b6f4-4bbe-9c40-35acb45419a7SPL set ID de3b6b64-dfa5-4abd-ba43-4ab59b4c2284RxCUI 309368UNII G07GZ97H65UPC 0010939045331
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N449348079376followed by a unit qualifier and the quantityPackage 49348-0793-76. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074165
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | Preferred Pharmaceuticals Inc. | 68788-8491 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | A-S Medication Solutions | 50090-7376 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | Walgreens | 0363-0220 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | H2-Pharma, LLC | 61269-220 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | Preferred Pharmaceuticals Inc. | 68788-8330 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-154 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | Cardinal Health (Leader) 70000 | 70000-0729 |